Sponsor Oversight Old

Zenovel commitment to seamless sponsor oversight

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The sponsor holds sole accountability for management and monitoring of clinical trials. Therefore, there should be systems in place to ensure that contracted or outsourced tasks are being closely monitored guaranteeing patient wellbeing and data integrity.

Regulatory Expectations:

When Regulators come to inspect the Sponsor oversight system, they expect following system in place:

Documentation of the selection process and credentials of the CRO they are collaborating with, ensuring that CRO adheres to the suitable rules and regulations.
A contractual agreement that clearly assigns responsibilities and duties.
A tripartite agreement if the CRO has subcontracted any work.
A sponsor oversight mechanism to monitor the on-going trials and ensure the CRO adheres to sponsor specification and ICH-GCP guidelines.

USFDA has recommended the “Guidance for Industry Oversight of Clinical Investigations – — A Risk-Based Approach to Monitoring” emphasizing the importance of effective monitoring to protect human subjects and ensure high-quality studies. Sponsors of clinical investigations involving human drugs are required to provide oversight to ensure the rights, welfare, and safety of subjects and the quality of clinical trial data submitted to the FDA.

As per ICH E6 R2, the sponsor may establish an independent data monitoring committee (IDMC) to assess the progress of a clinical trial, including safety data and critical efficacy endpoints. The IDMC should have written operating procedures and maintain records of meetings. The sponsor should ensure oversight of trial-related duties and functions carried out on its behalf, including those subcontracted to another party by the sponsor’s contracted CRO(s).

Zenovel’s Array of Services

Zenovel provides array of services for seamless sponsor oversight:

Selection and Qualification
Appropriate Contracts and Agreements
Risk Evaluation and Management
Quality Assurance
Trial Oversight
Vendor Oversight
Regulatory Compliance

Our Approach:

Contracts and agreement:

Contracts and agreement : Adherence to GCP is crucial and should be prioritized over internal policies and procedures. The contract should address subcontracting and outline the sponsor’s oversight of additional subcontracting. However, key legislative requirements, such as reporting urgent safety measures and serious breaches, are often missing from contracts, potentially leading to non- compliance due to unclear roles and responsibilities.

Oversight Mechanism:

Vendor assessment : is essential before using a vendor and can serve as a continuous assessment mechanism. This can involve reviewing the vendor's Quality Management System (QMS), standard operating procedures (SOPs), site visits, or audits. In cases of multiple vendors, a communication plan should be in place, outlining processes and procedures for each party to follow, especially in case of potential breaches.

Performance reviews are crucial in identifying and rectifying non-compliances in trials. Inspectors may ask sponsors why they continue using certain products and if any mitigation were implemented to prevent recurrence.

Project meetings and status/metric reports : are crucial for tracking trial progress, as they help identify potential issues and provide guidance on how to resolve them. A serious breach occurred when a packaging issue was not rectified, leading to a fatal overdose of IMP.

Documentation Review and Approval : Sponsors should demonstrate oversight by reviewing and approving documentation such as Monitoring Visit Reports, Data Management Plans, Statistical Analysis Plans, deviation logs, and audit trails. It is essential to clearly define which documents are required for review within the sponsor's QMS and what the review entails.

Co-monitoring Visits and CAPA : Clear documentation of co-monitoring visits, activities performed, and identified issues should be provided, along with an appropriate Corrective and Preventative Action Plan (CAPA).

Prompt issue notification: The sponsor should be promptly notified of any issues, including potential serious breaches, through procedures that identify and escalate them to the sponsor within 7 days. This process starts as soon as anyone working on behalf of the sponsor, including vendors, identifies the issue.

Zenovel maintains the highest standards for safeguarding patients and ensuring data authenticity through comprehensive supervision procedures, guaranteeing efficient management and monitoring of clinical studies.

Zenovel, your trusted partner for Regulatory Compliance and Clinical Research Quality Assurance

GCP

Zenovel, your trusted partner for Regulatory Compliance and Clinical Research Quality Assurance

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Zenovel, your trusted partner for Regulatory Compliance and Clinical Research Quality Assurance

Zenovel, your trusted partner for Regulatory Compliance and Clinical Research Quality Assurance